Pembrolizumab (Immunotherapy Drug) in Combination With Guadecitabine and Mocetinostat (Epigenetic… (NCT03220477) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Pembrolizumab (Immunotherapy Drug) in Combination With Guadecitabine and Mocetinostat (Epigenetic Drugs) for Patients With Advanced Lung Cancer.
United States28 participantsStarted 2017-08-04
Plain-language summary
The purpose of this study is to test the safety of a combination of three drugs, pembrolizumab, guadecitabine and mocetinostat. Pembrolizumab is a drug given by vein and all patients will receive the same dose. Guadecitabine and mocetinostat will be given at different doses to find out what effects, if any, they have on treating your cancer and side effects.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Pretreatment tissue should be collected via core biopsy, ideally of a non-target lesion.
. Patients may not have intervening systemic anti-cancer therapy between the time of pre-treatment biopsy/resection and initiating study treatment.
. Women of childbearing potential must agree to practice 2 effective methods of contraception from the time of signing the informed consent form through 120 days after the last dose of study therapy, or agree to completely abstain from heterosexual intercourse.
. Male subjects, even if surgically sterilized (i.e., status post vasectomy) must agree to 1 of the following: practice effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study therapy, or agree to completely abstain from heterosexual intercourse.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combines three drugs — pembrolizumab, guadecitabine, and mocetinostat — and it's a Phase 1 study, which means the main focus is on safety and finding the right dose rather than proving the treatment works; given that, what does my doctor think the risk-to-benefit balance looks like for someone in my situation compared to standard treatment options?
2Since the trial is actively enrolling patients but is no longer recruiting, does my doctor know whether there are any similar Phase 1 or Phase 2 studies combining immunotherapy with epigenetic drugs that I might still be eligible for?
3The trial is measuring how many patients experience adverse events, which tells me safety is still being worked out for this three-drug combination — are there specific side effects from combining an immune checkpoint inhibitor like pembrolizumab with these two epigenetic drugs that my doctor would want to watch closely if I were on something like this?
4Because this is a Phase 1 trial for advanced lung cancer, what standard or approved treatments would my doctor recommend first, and under what circumstances would enrolling in a study like this make more sense than starting with those options?
5The trial is also measuring response rate in the Phase Ib portion — has my doctor seen any early signals or published data from this study that would help us understand whether this combination has shown any meaningful activity in lung cancer patients like me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.